Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

The first participant entered the study on 08 Jun 2007, and the last participant completed the study on 19 Jan 2010. The study was conducted at 167 centers in Japan. 164 study centers enrolled at least 1 participant.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

In total, 1439 participants were screened for study eligibility; 159 participants were screening failures and were not randomized. Therefore, 1280 participants (640 in each group) were randomized.

Reporting Groups

Description

Rivaroxaban (Xarelto, BAY59-7939)

Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period

Warfarin

Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Participant Flow for 2 periods

Period 1: Double-blind (DB) Treatment Period

Rivaroxaban (Xarelto, BAY59-7939)

Warfarin

STARTED

640

640

Started Treatment

639 [1]

639 [1]

COMPLETED

480

468

NOT COMPLETED

160

172

Adverse Event

73

70

Withdrawal by Subject

26

35

Death

8

3

Physician Decision

4

13

Lost to Follow-up

4

1

Protocol Violation

9

9

Clinical Endpoint Reached

18

28

Non-compliant with Study Medication

3

1

Protocol Driven Decision Point

12

8

Site Closed by Investigator

1

2

Site Closed by Sponsor

1

1

Drop out before Treatment Start

1

1

[1]

Safety population

Period 2: Follow-up (FU) Period

Rivaroxaban (Xarelto, BAY59-7939)

Warfarin

STARTED

639 [1]

639 [1]

Entered FU and Valid for Safety

628 [2]

630 [2]

COMPLETED

610

616

NOT COMPLETED

29

23

Adverse Event

1

1

Death

13

12

Lost to Follow-up

6

2

Physician Decision

0

1

Protocol Violation

1

0

Withdrawal by Subject

5

5

Clinical Endpoint Reached

3

2

[1]

All treated participants were to enter FU period, whether or not they completed the DB period

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

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Reporting Groups

Description

Rivaroxaban (Xarelto, BAY59-7939)

Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period

Warfarin

Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.